A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

Purpose

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Condition

  • Acute Pain

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Before Surgery: - Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) - After Surgery: - Participant is lucid and able to follow commands - All analgesic guidelines were followed during and after the bunionectomy

Exclusion Criteria

  • Before Surgery: - Prior history of bunionectomy or other foot surgery on the index foot - History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years - A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses - After Surgery: - Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-993 		Participants will be randomized to receive different dose levels of VX-993.
  • Drug: VX-993
    Tablets for oral administration.
  • Drug: Placebo (matched to HB/APAP)
    Placebo matched to HB/APAP for oral administration.
Active Comparator
Hydrocodone bitartrate/acetaminophen (HB/APAP) 		Participants will be randomized to receive HB/APAP.
  • Drug: HB/APAP
    Capsules for oral administration.
  • Drug: Placebo (matched to VX-993)
    Placebo matched to VX-993 for oral administration.
Placebo Comparator
Placebo 		Participants will be randomized to receive placebos matched to VX-993 and HB/APAP.
  • Drug: Placebo (matched to VX-993)
    Placebo matched to VX-993 for oral administration.
  • Drug: Placebo (matched to HB/APAP)
    Placebo matched to HB/APAP for oral administration.

Recruiting Locations

Memorial Hermann Village
Houston, Texas 77043

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com